SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
FDA Device Recall #Z-1133-2018 - Class II, December 20, 2017
Recall Summary
| Recall Number | Z-1133-2018 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 20, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific Corporation |
| Location | Marlborough, MA |
| Product Type | Devices |
| Quantity | 5026 |
Product Description
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Reason for Recall
Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
Distribution Pattern
Worldwide Distribution US nationwide, Austria, Belarus, Belguim, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Bahrain, China, Hong Kong, India, Malaysia, Pakistan, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Thailand, Tunisia, Turkey, Vietnam, Brazil, Canada, Cost Rica, Ecuador, Guatemala, Mexico, Peru
Lot / Code Information
21071349 21186199 21264281 21338493 21072506 21186874 21264826 21339969 21097205 21189216 21268628 21346857 21099913 21192332 21269880 21348369 21101809 21194784 21275009 21348655 21104860 21196427 21279183 21351508 21106212 21196815 21280166 21354138 21111667 21197475 21282419 21355128 21112353 21198355 21284302 21356067 21120166 21201164 21285174 21359495 21121467 21203598 21285708 21360857 21125598 21204762 21287283 21361914 21129863 21207916 21291325 21366469 21134585 21210287 21291903 21368941 21136699 21212151 21295990 21372468 21139834 21215249 21301969 21373463 21143014 21216252 21302617 21373946 21 150144 21218379 21305351 21377827 21150932 21220903 21307321 21380698 21156170 21221247 21308963 21381638 21159396 21226282 21310860 21385327 211 60496 21227147 21311361 21387164 21163684 21233949 21313025 21387745 2 1164861 21235402 21313392 21391319 21165772 21237929 21315518 21393249 211 68729 21240546 21316968 21393900 21169977 21241587 21317017 21395015 21170814 21245984 21322828 21395016 21174026 21246770 21324197 21401047 211 75845 21249893 21324851 21401048 211 76842 21251968 21329021 21401049 21180343 21253001 21329708 21413940 21181253 21254244 21332229 21414750 21181677 21257214 21334848 21420240 21186002 21260915 21335787
Other Recalls from Boston Scientific Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3082-2026 | Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardia... | Aug 6, 2026 |
| Z-3083-2026 | Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardia... | Aug 6, 2026 |
| Z-3081-2026 | Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardia... | Aug 6, 2026 |
| Z-2962-2026 | Class II | Suture Cinch Long 1pk. Endoscopic tissue app... | Jul 14, 2026 |
| Z-2961-2026 | Class II | OverStitch Suture Cinch, 1pk. Endoscopic tissue... | Jul 14, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.